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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 213383
Company: DR REDDYS

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DASATINIB DASATINIB 20MG TABLET;ORAL Prescription AB No No
DASATINIB DASATINIB 50MG TABLET;ORAL Prescription AB No No
DASATINIB DASATINIB 70MG TABLET;ORAL Prescription AB No No
DASATINIB DASATINIB 80MG TABLET;ORAL Prescription AB No No
DASATINIB DASATINIB 100MG TABLET;ORAL Prescription AB No No
DASATINIB DASATINIB 140MG TABLET;ORAL Prescription AB No No

Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
03/03/2025 ORIG-1 Approval STANDARD Letter (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/213383Orig1s000TAltr.pdf

DASATINIB

TABLET;ORAL; 20MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DASATINIB DASATINIB 20MG TABLET;ORAL Prescription No AB 202103 APOTEX
DASATINIB DASATINIB 20MG TABLET;ORAL Prescription No AB 217217 BIOCON PHARMA
DASATINIB DASATINIB 20MG TABLET;ORAL Prescription No AB 213383 DR REDDYS
DASATINIB DASATINIB 20MG TABLET;ORAL Prescription No AB 216547 EUGIA PHARMA
DASATINIB DASATINIB 20MG TABLET;ORAL Prescription No AB 218719 ZYDUS PHARMS
SPRYCEL DASATINIB 20MG TABLET;ORAL Prescription Yes AB 021986 BRISTOL MYERS SQUIBB

TABLET;ORAL; 50MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DASATINIB DASATINIB 50MG TABLET;ORAL Prescription No AB 202103 APOTEX
DASATINIB DASATINIB 50MG TABLET;ORAL Prescription No AB 217217 BIOCON PHARMA
DASATINIB DASATINIB 50MG TABLET;ORAL Prescription No AB 213383 DR REDDYS
DASATINIB DASATINIB 50MG TABLET;ORAL Prescription No AB 216547 EUGIA PHARMA
DASATINIB DASATINIB 50MG TABLET;ORAL Prescription No AB 218719 ZYDUS PHARMS
SPRYCEL DASATINIB 50MG TABLET;ORAL Prescription Yes AB 021986 BRISTOL MYERS SQUIBB

TABLET;ORAL; 70MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DASATINIB DASATINIB 70MG TABLET;ORAL Prescription No AB 202103 APOTEX
DASATINIB DASATINIB 70MG TABLET;ORAL Prescription No AB 217217 BIOCON PHARMA
DASATINIB DASATINIB 70MG TABLET;ORAL Prescription No AB 213383 DR REDDYS
DASATINIB DASATINIB 70MG TABLET;ORAL Prescription No AB 216547 EUGIA PHARMA
DASATINIB DASATINIB 70MG TABLET;ORAL Prescription No AB 218719 ZYDUS PHARMS
SPRYCEL DASATINIB 70MG TABLET;ORAL Prescription Yes AB 021986 BRISTOL MYERS SQUIBB

TABLET;ORAL; 80MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DASATINIB DASATINIB 80MG TABLET;ORAL Prescription No AB 203180 APOTEX
DASATINIB DASATINIB 80MG TABLET;ORAL Prescription No AB 217217 BIOCON PHARMA
DASATINIB DASATINIB 80MG TABLET;ORAL Prescription No AB 213383 DR REDDYS
DASATINIB DASATINIB 80MG TABLET;ORAL Prescription No AB 216547 EUGIA PHARMA
DASATINIB DASATINIB 80MG TABLET;ORAL Prescription No AB 218719 ZYDUS PHARMS
SPRYCEL DASATINIB 80MG TABLET;ORAL Prescription Yes AB 021986 BRISTOL MYERS SQUIBB

TABLET;ORAL; 100MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DASATINIB DASATINIB 100MG TABLET;ORAL Prescription No AB 202103 APOTEX
DASATINIB DASATINIB 100MG TABLET;ORAL Prescription No AB 217217 BIOCON PHARMA
DASATINIB DASATINIB 100MG TABLET;ORAL Prescription No AB 213383 DR REDDYS
DASATINIB DASATINIB 100MG TABLET;ORAL Prescription No AB 216547 EUGIA PHARMA
DASATINIB DASATINIB 100MG TABLET;ORAL Prescription No AB 218719 ZYDUS PHARMS
SPRYCEL DASATINIB 100MG TABLET;ORAL Prescription Yes AB 021986 BRISTOL MYERS SQUIBB

TABLET;ORAL; 140MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DASATINIB DASATINIB 140MG TABLET;ORAL Prescription No AB 203180 APOTEX
DASATINIB DASATINIB 140MG TABLET;ORAL Prescription No AB 217217 BIOCON PHARMA
DASATINIB DASATINIB 140MG TABLET;ORAL Prescription No AB 213383 DR REDDYS
DASATINIB DASATINIB 140MG TABLET;ORAL Prescription No AB 216547 EUGIA PHARMA
DASATINIB DASATINIB 140MG TABLET;ORAL Prescription No AB 218719 ZYDUS PHARMS
SPRYCEL DASATINIB 140MG TABLET;ORAL Prescription Yes AB 021986 BRISTOL MYERS SQUIBB
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